IRB & Research Regulatory Specialist

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

The Research Regulatory Specialist at The Medical College of Wisconsin is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing reviews for human subject research, ensuring compliance with federal, state, and institutional procedures.

This role serves as the regulatory liaison with sponsors, PI and study teams, supporting successful conduct of research projects and adherence to regulatory requirements.

Qualifications

• Bachelor’s degree required.
• 2 years in compliance or healthcare field.
• CITI certification required within 30 days of hire.
• SoCRA and ACRP certification preferred.
• Experience may be substituted for education on an equivalent basis.

Responsibilities

• Provide primary administrative support for the preparation of IRB documents.
• Draft and submit protocols, amendments, deviations, adverse events, continuing progress reports, and consent documents.
• Modify documents to meet IRB guidelines and program requirements.
• Submit documents in the institution's electronic IRB system for initial approval, amendments and continuing reports.
• Review submissions for accuracy, completeness, and compliance using checklists.

Skills

Regulatory compliance

Excellent communication

Attention to detail

Critical thinking

Documentation skills

Education

Bachelor’s degree

Tools

CTMS

IRB submission systems

Job description

The Research Regulatory Specialist at The Medical College of Wisconsin is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing reviews for human subject research, ensuring compliance with federal, state, and institutional procedures.

This role serves as the regulatory liaison with sponsors, PI and study teams, supporting successful conduct of research projects and adherence to regulatory requirements.